Depression
Conditions
Brief summary
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from \ 15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.
Detailed description
Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from \ 15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention. Meditative internal focus has been shown to benefit depression. Our own research shows that the neural correlates of attention-to-breath are associated with greater mindfulness. Hence, in this study we will pair breath training with rTMS neuro-stimulation.
Interventions
DEVICEMedi1TMS
rTMS theta-burst protocol paired with a consistent attention-to-breath task
DEVICEMedi2TMS
rTMS theta-burst protocol paired with an intermittent deep breathing task
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* moderate to severe depression (PHQ-9 scale score \>9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders) * treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode)
Exclusion criteria
* active substance abuse/dependence * psychotic disorders * any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder). * displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Clinical Depression (Remission) | up to 6 weeks | Remission is defined by achieving \<5 score on the Patient Health Questionnaire 9-item depression scale at post-intervention. This scale ranges in score from 0-27; higher score is worse depression. |
| Change From Baseline Brain Activity in Attention-to-breath Task | up to 6 weeks | Change from baseline brain activity is specifically change in source-localized electroencephalography (EEG) alpha band power. The unit of measure is log (uA/mm\^2), which represents the transformation of EEG signals recorded at scalp electrodes in microvolts into a log-scaled estimate of cortical current source density after source reconstruction. A value of 0 means the current density is exactly 1 since log(1) = 0. Negative values indicate weak cortical source currents fractional to a microampere (e.g. -1 equals 0.1 uA/mm\^2). Positive values represent stronger activity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJyoti Mishra, PhD
University of California, San Diego
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 15.2 |
| Baseline brain activity in attention to breath task | -6.75 log (uA/mm^2) STANDARD_DEVIATION 1.28 |
| Baseline Depression (PHQ9 scale) | 14.04 Scale with score range from 0-27 STANDARD_DEVIATION 4.22 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
None listed